Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 7-17, 19-20, 24, 26-30, 36-37, and 39-40 were canceled.
Claims 1-6, 18, 21-23, 25, 31-35, 38, and 41-44 are pending.
Claims 1-6, 25, 31, 34, 38, and 42-44 were withdrawn from further consideration (see below).
Claims 18, 21-23, 32-33, 35 and 41 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/2/2026 is acknowledged.
Claim(s) 1-6, 25, 31, 34, 38, and 42-44 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/2/2026.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in [0205] at page 54; and in [0231] at page 61. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Specification
The disclosure is objected to because instant sequence listing disclosed sequence “000” for SEQ ID NO: 117. This type of skipped sequence error happens when Applicant assigned SEQ ID NO for three amino acids or fewer. Applicant must correct errors for compliance with 37 CFR 1.835. Sequence identifier must not be assigned to the sequence of three or fewer amino acid residues. Applicant must replace “SEQ ID NO: 117” with actual sequence throughout instant specification if SEQ ID NO: 117 is three amino acids or fewer.
Appropriate correction is required. See ST.26 rules.
Drawings
The disclosure is objected to because page 8 of Drawings is labeled as “FIG. 1B(cont.)” but page 9 is labeled as “FIG. 1C”. Therefore, it is not clear whether page 9 is part of FIG. 1B or it is FIG. 1C. Furthermore, figure legend for Figure 1C is not about amino acid sequence shown at page 9 of Drawing. In addition, page 10 is labeled as “FIG. 1C(cont.)”. It is not clear if both page 9 and 10 are FIG. 1C or if only page 10 is FIG. 1C.
Specification / Drawings
The disclosure is objected to because they depict nucleic acid and/or amino acid sequences, which is not identified by sequence identification numbers in Figure 1C and Figure 16D. While figure legend for figure 16D disclosed SEQ ID NOs for other sequences, it did not disclose SEQ ID NO for 2MA2_T4C2S in Figure 16D. Applicant must provide appropriate amendments to the specification inserting the required sequence identifiers.
Appropriate action correcting this deficiency is required. If any sequences are not in the current sequence listing, Applicant must submit paper and computer-readable copies of a substitute sequence listing, together with an amendment directing its entry into the specification and a statement that the content of both copies are the same and, where applicable, include no new matter.
Sequences appearing in the specification and/or drawings must be identified by a sequence identifier in accordance with 37 C.F.R. 1.821(d); sequence identifiers for sequences appearing in the drawings may appear in the drawings or in the brief description of the drawings.
Appropriate correction is required.
Claim Objections
Claim 18 is objected to because of the following informalities: “and wherein” in line 28 must be deleted to be consistent with other conditions (a)-(c) and because it may cause confusion because condition (d) is already a part of wherein-clause. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18, 21-23, 32-33, 35 and 41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 and 23 recites “XXXWF (SEQ ID NO: 117)” in line 18. However, instant sequence listing has “000” for SEQ ID NO: 117. This type of skipped sequence error happens when Applicant assigned SEQ ID NO for three amino acids or fewer. Therefore, it is not clear if SEQ ID NO: 117 is assigned to five amino acid sequence of “XXXWF” according to instant claim 18 or if SEQ ID NO: 117 is assigned to three amino acid or fewer according to instant sequence listing.
Claim 18 and 23 recites “XXXWF (SEQ ID NO:117), wherein (a) amino acids W and F at positions 4 and 5 respectively are retained and at least one X at positions 1, 2 and 3 is substituted with a conservative or non-conservative amino acid; (b) amino acids W and F at positions 4 and 5 respectively are retained and conservative amino acid substitutions of X are made at positions 1, 2 and 3; (c) amino acids W and F at positions 4 and 5 respectively are retained, the X at positions 1 and 3 are independently amino acid S, a conservative amino acid or a non-conservative amino acid, and the X at position 2 is amino acid K, a conservative amino acid or a non-conservative amino acid; and (d) amino acid W at position 4 or amino acid F at position 5 is substituted with a conservative amino acid, and wherein the X at positions 1 and 3 are independently amino acid S, a conservative amino acid or a non-conservative amino acid, and the X at position 2 is K, a conservative amino acid or a non-conservative amino acid”. Because instant sequence listing and instant specification did not disclose what amino acid is allowed at XXX at position 1-3, there is no reference to determine which amino acid is conservative amino acid or non-conservative amino acid. Therefore, it is unclear how can one of ordinary skill in the art determine which amino acid is conservative amino acid or non-conservative amino acid to substitute for XXX at position 1-3.
Furthermore, four conditions (a)-(d) within wherein-clause are connected by conjunction “and” in line 26. It is unclear how all four different conditions are simultaneously met by wherein-clause because conjunction “and” was used. For example, condition (c) requires that amino acids W and F at positions 4 and 5 respectively are retained and condition (d) requires that amino acid W at position 4 or amino acid F at positions 5 is substituted with a conservative amino acid. How can same amino acid W at position 4, for example, be retained and at the same time be substituted due to conjunction “and” before condition (d)? If Applicant intends to recite four different alternative conditions by wherein-clause of claim 18, it is suggested that Applicant amend conjunction “and” in line 26 of claim 18 to conjunction “or”.
Claim 18 and 23 recites SEQ ID NO: 2. There is discrepancy between SEQ ID NO: 2 disclosed by instant sequence listing and SEQ ID NO: 2 disclosed at page 22 of instant specification. SEQ ID NO: 2 disclosed by instant sequence listing has extra 20 amino acids at N-terminus. Therefore, it is unclear what sequence Applicant intends to recite by SEQ ID NO: 2.
Claim 23 depends from claim 20 which is already canceled. For purposes of compact prosecution, claim 23 is treated as a claim depending from claim 18. However, this treatment does not relieve applicant of the burden of responding to this rejection.
Dependent claims are also rejected because they depend from claim 18 and do not cure the deficiency.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18, 21-23, 32-33, 35 and 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Analysis
Instant claim 18 and 23 recites “a polypeptide comprising XXXWF (SEQ ID NO: 117)” in line 18. In case of condition (a) for this peptide, XXX at position 1-3 can be substituted by any amino acid because any amino acid is a conservative or non-conservative amino acid. Therefore, “a polypeptide comprising XXXWF (SEQ ID NO: 117)” recited by instant claim 18 encompasses 19 x 19 x 19 = 6,859 species polypeptides. However, instant specification disclosed D7M9 peptide comprising AKSWF, D7M10 peptide comprising SASWF, D7M11 peptide comprising SKAWF, D7M12 peptide comprising SKSAF, D7M13 peptide comprising SKSWA, D8M4 peptide comprising AKSWF, D8M5 peptide comprising SASWF, D8M6 peptide comprising SKAWF, D8M7 peptide comprising SKSAF, D8M8 peptide comprising SKSWA (page 64-65). Therefore, instant specification disclosed five species of substitution of “XXXWF” wherein each position was substituted with A. Only five species substitution cannot be considered as a representative number of species falling within the scope of genus encompassing at least 6,859 species substitution of “XXXWF” recited by instant claim 18.
In the unpredictable art like instant invention, one of ordinary skill in the art cannot predict that any and all possible peptides comprising substitution of “XXXWF” with any possible amino acid will still function as vaccine composition as five species of substitution of “XXXWF” with only alanine disclosed by instant specification. In the field of protein modification technology, a change of a single amino acid residue may change the properties of the protein. Sickle cell anemia, for example, results from a mutation in just one of 574 amino acids. For example, Prengler et al (Ann Neurol 2002;51:543-552; PTO-892) teaches that one amino acid substitution valine for glutamic acid at the sixth position of the beta-globin chain cause sickle cell anemia (page 544, left column, third paragraph). Witkowski et al (Biochemistry 38:11643-11650, 1999; PTO-892) teach that one conservative amino acid substitution transforms a B-ketoacyl synthase into a malonyl decarboxylase and completely eliminates B-ketoacyl synthase activity. Seffernick et al., (Bacteriol. 183(8): 2405-2410, 2001; PTO-892) teach that two naturally occurring Pseudomonas enzymes having 98% amino acid sequence identity catalyze two different reactions: deamination and dehalogenation, therefore having different function. It is not always possible to make variants that retain activity if the regions have been altered.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genus. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18 and 21-22 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to a polypeptide comprising the amino acid sequence SEQ ID NO: 2 which is a natural protein. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The MPEP Section 2103 through 2106 provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101.
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a composition of matter, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to a polypeptide comprising the amino acid sequence SEQ ID NO: 2 which is a natural protein. Although SEQ ID NO: 3-6 contain N-terminal signal peptide and C-terminal his-tag, instant SEQ ID NO: 2 does not contain these sequences and therefore SEQ ID NO: 2 is a sequence for natural protein. Furthermore, peptides C10-C12 and D01-D08 are portion of SEQ ID NO: 2 (instant specification page 24, paragraph 0084). Therefore, a polypeptide comprising these peptides also encompass SEQ ID NO: 2. For example, a polypeptide comprising SEQ ID NO: 7 (C10 peptide) claimed by instant claim 18 encompasses SEQ ID NO: 2 because SEQ ID NO: 7 is a portion of SEQ ID NO: 2 and the transitional phrase “comprising” is open-ended and does not exclude additional unrecited elements. Therefore, these polypeptides comprising a portion of SEQ ID NO: 2 also encompass natural proteins.
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, claims 18 and 21-22 do not recite additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 18, 21-23 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuen et al (US2009/0305282; PTO-892).
Regarding claim 18, Yuen teaches human coronavirus HKU1 ORF3 translated protein fragment, SEQ ID 1286 which comprises instant SEQ ID NO: 81 (SCV; duplicate of result 4 of 81.rag).
result 4 of 81.rag
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Regarding claim 21-22, as evidenced by instant specification at page 22, instant SEQ ID NO: 2 is amino acid sequence for TDX1557. The sequence “SKSWF” is a portion of instant SEQ ID NO: 2. Therefore, the polypeptide of Yuen comprises 5 amino acids of TDX1557 (instant SEQ ID NO: 2).
Regarding claim 23, as shown above, the polypeptide of Yuen has 12 amino acids and comprises at least 5 contiguous amino acids “SKSWF” as set forth in SEQ ID NO: 2 and SEQ ID NO: 81.
Regarding claim 32, Yuen teaches “the invention provides immunogenic and vaccine preparations using recombinant and chimeric forms as well as subunits of the CoV-HKU1 based on the nucleotide sequences and deduced amino acid sequences of the CoV-HKU1” (abstract).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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